FDA Rejects Pair Of Gilead HIV Drugs

Law360, New York (April 29, 2013, 7:32 PM EDT) -- Gilead Sciences Inc. said Monday that the Food and Drug Administration rejected its applications to market two HIV treatment drugs, elvitegravir and cobicistat, as standalone drugs, because of problems with quality-testing methods.

The drugs already are approved as components of Gilead's HIV treatment Stribild, a once-a-day tablet made up of elvitegravir and cobicistat as well as emtricitabine and tenofovir disoproxil fumarate. The company said the decision will not affect its marketing of Stribild.

The FDA told Gilead it had found “deficiencies in documentation and validation of...